Analytical goals for accuracy and precision of plasma creatinine determinations evaluated by reference method...

Area of Science:

• Clinical chemistry
• Analytical methodology

Background:

• Establishing analytical performance goals is crucial for reliable diagnostic testing.
• Both medical needs and biological variation are key considerations for setting these goals.

Purpose of the Study:

• To assess analytical accuracy and precision goals using medical needs and biological variation approaches.
• To evaluate a representative clinical method against a reference method.

Main Methods:

• Utilized "medical needs" and biological variation frameworks to define goals.
• Expressed accuracy goals as relative deviations (0.072-0.15).
• Estimated precision goals as relative standard deviations (0.022-0.14).
• Compared a clinical method to a reference method for evaluation.

Main Results:

• Accuracy goals were achieved at high analyte levels but not at low levels.
• Precision goals were met based on medical needs.
• Precision goals were not met with respect to biological variation.

Conclusions:

• Current clinical methods may not consistently meet all analytical performance criteria, particularly at low concentrations.
• The choice of reference (medical needs vs. biological variation) significantly impacts the assessment of analytical method performance.
• Further method optimization may be required to address limitations in accuracy at low levels and precision relative to biological variation.